FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Even the best labs can incur CLIA deficiencies when unprepared; this checklist can help your lab avoid some of the most common
Areas to address when preparing for your next CLIA inspection, based on recent data on top CLIA deficiencies
The new rule, slated to go into effect September 4, will ban noncompete agreements for most workers, including those in the lab industry
How labs form an indispensable part of the CMS National Quality Strategy, helping to drive healthcare improvements and scientific growth.
Genetic testing related fraud was a theme in recent enforcement actions involving medical laboratories and lab testing
Quality expert Sten Westgard discusses the latest CLIA update: “It’s time to have performance goals built in this century”
Lighthouse Lab Services chief quality officer Anna Hill offers advice on keeping your lab compliant with the latest CLIA changes.
What clinical laboratory professionals need to know about healthcare provision for transgender and nonbinary patients
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions